Painful lumbar radiculopathy (PLR) and painful diabetic neuropathy (PDN) affect approximately 40 million patients in EU and US. Currently there is no registered drug for PLR and around 50% of patients with PDN are inadequately treated.
The pain associated with PLR and PDN originates from diseased sensory neurons that mediate sensations including pressure and heat from arms and legs to the spinal cord and brain. In PLR, a physical compression of the sensory nerves entering the spinal cord causes a pain known as sciatica, while the sensory neuropathy and pain in PDN are caused by metabolic injury. For both PLR and PDN there is a great medical need for tolerable therapies like NeuRepair that can protect, restore, and regenerate sensory neurons and thereby ameliorate the pain.
With its unique and reparative mechanism, NeuRepair is poised to become a first-in-class biotherapeutic and has demonstrated clinically meaningful effects in both a phase I multi ascending dose study and in a multicenter phase IIa proof -of-concept study in chronic sciatica. Encouraged by these positive clinical data we commence further clinical development in a multicenter phase IIb study in chronic sciatica and start a multicenter phase IIa study in PDN.